Apparatus for subcutaneous electrode insertion

Abstract

Devices and methods for electrode implantation. A first embodiment includes an electrode insertion tool adapted to tunnel through tissue and attach, at its distal end, to a lead, such that the lead may be pulled into the tunneled space as the electrode insertion tool is removed. Additional embodiments include methods for inserting electrode/lead assemblies, including a method wherein an insertion tool is first used to tunnel through tissue, then to pull an electrode/lead into the tunneled space. In a further embodiment the insertion tool is next used, with a splittable sheath disposed thereon, to create an additional path into tissue, after which the insertion tool is removed, leaving the sheath in place; a lead is inserted to the sheath, and, finally, the splittable sheath is removed over the lead.

1 . A tool for inserting a lead electrode assembly subcutaneously, the tool comprising:
 a handle; and   a shaft having a proximal end and a distal end, the shaft being secured near its proximal end to the handle and including an attachment feature near its distal end for attaching to a lead electrode assembly, the distal end being shaped for advancement through tissue;   wherein:   the shaft further defines a lumen extending therein to a distal infusion port;   the attachment feature is a suture hole adapted to receive a suture therethrough and configured to allow a suture to be used to secure the tool to a lead for insertion of the lead into the body of a patient; and   the distal infusion port opens into the suture hole.   
     
     
         2 . The tool of  claim 1 , wherein the shaft is a rigid shaft and is generally straight distal of the handle. 
     
     
         3 . The tool of  claim 1 , wherein the shaft is a rigid shaft and includes a curved portion distal of the handle, the distal end of the rigid shaft having an axial direction that is at an angle with respect to an axial direction of the handle, the angle being between about 30 degrees and about 90 degrees. 
     
     
         4 . The tool of  claim 3 , wherein the angle is about 75 degrees. 
     
     
         5 . The tool of  claim 1 , wherein the shaft is a rigid shaft and comprises an elongate metallic tubular member having an offset curve near its proximal end, the handle being secured over the offset curve. 
     
     
         6 . A lead electrode assembly insertion kit comprising:
 a lead insertion tool comprising a handle; and a shaft having a proximal end and a distal end, the shaft being secured near its proximal end to the handle and including an attachment feature near its distal end for attaching to a lead electrode assembly, the distal end being shaped for advancement through tissue; wherein:
 the shaft further defines a lumen extending therein to a distal infusion port; 
 the attachment feature is a suture hole adapted to receive a suture therethrough and configured to allow a suture to be used to secure the tool to a lead for insertion of the lead into the body of a patient; and 
 the distal infusion port opens into the suture hole; and 
   a splittable sheath having a longitudinal splitting line, the sheath defining a lumen sized to receive the tool.   
     
     
         7 . The kit of  claim 6  wherein the lead insertion tool is configured such that the shaft is a rigid shaft and is generally straight distal of the handle. 
     
     
         8 . The kit of  claim 6  wherein the lead insertion tool is configured such that the shaft is a rigid shaft and includes a curved portion distal of the handle, the distal end of the rigid shaft having an axial direction that is at an angle with respect to an axial direction of the handle, the angle being between about 30 degrees and about 90 degrees. 
     
     
         9 . The kit of  claim 8  wherein the lead insertion tool is configured such that the angle is about 75 degrees. 
     
     
         10 . The kit of  claim 6  wherein the lead insertion tool is configured such that the shaft is a rigid shaft and comprises an elongate metallic tubular member having an offset curve near its proximal end, the handle being secured over the offset curve. 
     
     
         11 . The kit of  claim 6  wherein the suture hole defines lateral openings aligned to receive a suture. 
     
     
         12 . The tool of  claim 1  wherein the suture hole defines lateral openings aligned to receive a suture .